|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00984867 |
|
Date of registration:
|
23/09/2009 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Dapagliflozin DPPIV Inhibitor add-on Study
|
|
Scientific title:
|
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin |
|
Date of first enrolment:
|
October 2009 |
|
Target sample size:
|
833 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00984867 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Argentina
|
Germany
|
Mexico
|
Poland
|
United Kingdom
|
United States
| | |
|
Contacts
|
|
Name:
|
Serge Jabbour, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Thomas Jefferson University, Philadelphia |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients with type 2 diabetes
- Patients who are not receiving treatment , or those who currently receive metformin,
sitagliptin or vildagliptin or the combination of these
- Patients will be screened by a blood test and only those who need additional therapy
can be enrolled
Exclusion Criteria:
- Patients with type 1 diabetes
- Patients with very poorly controlled diabetes
- Any clinically significant illness, which in the judgement of the investigator would
compromise the patient's safety or successful participation in the clinical study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Type 2 Diabetes
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: Dapagliflozin
|
|
Primary Outcome(s)
|
|
Adjusted Mean Change in HbA1c Levels
[Time Frame: Baseline to Week 24]
|
|
Secondary Outcome(s)
|
|
Adjusted Mean Change in Body Weight
[Time Frame: Baseline to Week 24]
|
|
Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of =0.7% Compared to Baseline
[Time Frame: Baseline to Week 24]
|
|
Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise
[Time Frame: Baseline to Week 24]
|
|
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg
[Time Frame: Baseline to Week 8]
|
|
Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c =8%
[Time Frame: Baseline to Week 24]
|
|
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
[Time Frame: Baseline to Week 24]
|
|
Secondary ID(s)
|
|
D1690C00010
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|